The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Device Description

The Evolution® RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9. 11. and 13 French diameters) is designed to rotate in either a uni-rotational or bi-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters.

The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in in either a uni-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The devices have a working length of 13.6 centimeters.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the medical device:

The provided document describes physical and mechanical performance testing for the Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set. It does not present a clinical study involving human patients or AI assistance. The "acceptance criteria" and "reported device performance" are based on engineering and laboratory tests.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
1. Fatigue and Binding Testing	Sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after 50 cycles of flexing no less than 90° in opposite directions. (Note: Predicate device had 40 cycles, this device required 10 additional cycles).	These predetermined acceptance criteria were met.
2. Handle Cycling Testing	Sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. (Corresponds to predicate device K061000).	These predetermined acceptance criteria were met.
3. Buckling Testing	Sheaths should not kink, buckle, or fracture, and remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. (Corresponds to predicate device K061000).	These predetermined acceptance criterion was met.
4. Pull Testing/Sheath Pull Assembly Testing	Each joint in the devices should withstand a minimum of 20 pounds of pull force, after being subjected to the previous tests. (Corresponds to predicate device K061000).	These predetermined acceptance criterion was met.
5. Testing of Reciprocating Action	The rotational mechanism should remain functional through 1000 cycles of alternating clockwise and counterclockwise rotation.	These predetermined acceptance criterion was met.
6. Testing of Continuous Clockwise Rotation	The rotational mechanism should remain functional through 1000 cycles of clockwise rotation.	These predetermined acceptance criteria were met.
7. Testing of Continuous Counterclockwise Rotation	The rotational mechanism should remain functional through 1000 cycles of counterclockwise rotation.	These predetermined acceptance criteria were met.
8. Peel Force Testing	The peel-away outer sheath of the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set should require a peel force of less than 8 pounds.	These predetermined acceptance criteria were met.
9. Biocompatibility Testing	Acceptable in vitro and in vivo results per ISO 10993-1:2009 for external communicating devices in contact with circulating blood for a limited duration (≤ 24 hours), including: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Partial Thromboplastin Time, C3a Complement Activation, SC5b-9 Complement Activation, and Pyrogenicity.	Biocompatibility was deemed acceptable.
10. Sterility Testing	Acceptable bioburden levels, endotoxin levels, and ethylene oxide and ethylene chlorohydrin residuals.	Sterility was deemed acceptable.

Regarding the other requested information:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (number of units tested) for any of the engineering or laboratory tests.
The data provenance is from Cook Vascular, Inc. in the U.S.A. The tests are described as prospective laboratory and engineering tests, performed to meet design requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device clearance is based on mechanical, physical, and biocompatibility testing, not on a diagnostic or interpretive task that would require expert human judgment to establish a "ground truth." Therefore, there were no specific clinical experts establishing ground truth in the context of the tests described. The "experts" would be the engineers and scientists conducting and evaluating the specified tests against predetermined performance criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is needed for ground truth. The tests described are objective engineering measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This document is for a medical device (dilator sheath) and does not involve AI or human "readers" evaluating images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone (algorithm-only) performance study was done. This device is a mechanical tool and does not employ an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the engineering and biocompatibility tests was based on predefined objective performance metrics and regulatory standards (e.g., "not kink, buckle, or fracture," "withstand a minimum of 20 pounds of pull force," "functional through 1000 cycles," "peel force of less than 8 pounds," and compliance with ISO 10993-1 for biocompatibility).

8. The sample size for the training set

This concept is not applicable as this is not an AI/machine learning device. There was no training set.

9. How the ground truth for the training set was established

This concept is not applicable as there was no training set.

Summary

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COOK VASCULAR INCORPORATED 1186 MONTGOMERY LANE VANDERGRIFT, PA 15690-6065 U.S.A. 4.845.8021 TOLL FREE: 800.245.4715 WWW.COOKMEDICAL.COM

JUL 0 | 2014

5.0 510(k) SUMMARY

Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set 21 CFR §870.1310 Date Prepared: July 1, 2014

Submitted By:

Applicant:	Cook Vascular, Inc.
. Contact:	Thomas J. Kardos
Applicant Address:	Cook Vascular, Inc.
	1186 Montgomery Lane
	Vandergrift, PA 15690
Contact Phone Number:	(724) 845-8621 x2225
Contact Fax Number:	(724) 845-2848

Device Information:
Trade Name:	Evolution® RL Controlled-Rotation Dilator Sheath Set
	Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set
Common Name:	Vessel Dilator for Percutaneous Catheterization
Classification Name:	Dilator, Vessel, for Percutaneous Catheterization
Regulation:	21 CFR §870.1310
Product Code:	DRE

Predicate Device:

The predicate device is the Evolution® Mechanical Dilator Sheath Set (Cook Vascular, . Inc., K061000).

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Cook Vascular, Inc. - Traditional 510(k)

Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014

Device Description:

Intended Use:

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Cook Vascular, Inc. - Traditional 510(k)

Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014

Comparison to Predicates:

The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are substantially equivalent to the predicate device, the Evolution® Mechanical Dilator Sheath Set (K061000), in that these devices have similar designs, methods of construction and operation, and indications for use.

Technological Characteristics:

ﻟﺴﻴﺮ,

The following tests have been conducted to ensure reliable design and performance under the specified design requirements. These tests include:

Fatigue and Binding Testing - Testing was performed with the requirement that the sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after 50 cycles of flexing no less than 90° in opposite directions. The results showed that these predetermined acceptance criteria were met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000. with the exception of requiring 10 additional cycles of flexing as compared to the acceptance criteria for the predicate.
Handle Cycling Testing - Testing was performed with the requirement that the sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. The results showed that these predetermined acceptance criteria were met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000.
Buckling Testing - Testing was performed with the requirement that the sheaths should not kink, buckle, or fracture should remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. The results showed that these predetermined acceptance criterion was met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000.
Pull Testing/Sheath Pull Assembly Testing - Testing was performed with the requirement that each joint in the devices should withstand a minimum of 20 pounds of pull force, after being subjected to the previous tests. The results showed that these predetermined acceptance criterion

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Cook Vascular, Inc. - Traditional 510(k) Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014

was met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000.

Testing of Reciprocating Action - Testing was performed with the requirement that the rotational mechanism should remain functional through 1000 cycles of alternating clockwise and counterclockwise rotation. The results showed that these predetermined acceptance criterion was met.
Testing of Continuous Clockwise Rotation - Testing was performed with the requirement that the rotational mechanism should remain functional through 1000 cycles of clockwise rotation. The results showed that these predetermined acceptance criteria were met.
Testing of Continuous Counterclockwise Rotation - Testing was performed with the requirement that the rotational mechanism should remain functional through 1000 cycles of counterclockwise rotation. Thus, the predetermined acceptance criteria were met.
Peel Force Testing - Testing shows that the peel-away outer sheath of the Evolution Shortie RL Controlled-Rotation Dilator Sheath Set should require a peel force of less than 8 pounds. Thus, the predetermined acceptance criteria were met.
Biocompatibility Testing - Per ISO 10993-1:2009. the proposed devices were classified as external communicating devices in contact with circulating blood for a limited (≤ 24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Partial Thromboplastin Time, C3a Completement Activation, SC5b-9 Complement Activation, and Pyrogenicity.
Sterility Testing - The proposed devices were evaluated for bioburden levels, endotoxin levels, and ethylene oxide and ethylene chlorohydrin residuals. Their sterility was deemed acceptable.

Conclusion:

The results of these tests support a conclusion that the Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set met the design input requirements based on the intended use and support the conclusion that these

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Cook Vascular, Inc. - Traditional 510(k) Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014

devices do not raise new questions of safety or effectiveness as compared to the predicate and are therefore substantially equivalent to the predicate device, the Evolution® Mechanical Dilator Sheath Set (Cook Vascular, Inc., K061000).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 1, 2014

Cook Vascular, Inc. Thomas Kardos Vice President, Regulatory Affairs 1186 Montgomery Lane Vandergrift, Pennsylvania 15690

Re: K141148

Trade/Device Name: 'Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catherization Regulatory Class: Class II Product Code: DRE Dated: May 2, 2014 Received: May 5, 2014

Dear Thomas Kardos,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-

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Page 2 - Thomas Kardos

related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Linda J. Ricci -S

for Bra

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K141148 P 7 Of

4.0 INDICATIONS FOR USE

INDICATIONS FOR USE

K141148 510(k) Number (if known):

Device Name: Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).